RFP 75N98023R00014 Questions and Answers Amendment 5.docx

RFP 75N98023R00014 Questions and Answers Amendment #5 Answers to Questions are in bold.

1. I’ve had the opportunity to examine the documents you published today for your procurement with respect to certification levels of surgical gowns under your procurement. The solicitation lists testing requirements under the heading of certification levels which necessitate further clarification. These testing standards applicable to surgical gowns include requirements for liquid barrier performance and flammability (ASTM F1670, ASTM F1671, ASTM F903, AATCC TM42, NFPA 701 or NFPA 2112, 16 CFR 1610) that potentially cover Levels 1 to 4 under AAMI PB70 classification. However, AAMI PB70 defines barrier levels for gowns between Levels 1 to 4 (and defines liquid barrier performance test standards at each level). As such, procurements for surgical gowns will generally request surgical gowns that have a specified AAMI PB70 protection level (ie Level 1 or 2 or 3 or 4). Will you please specify which AAMI PB70 level(s) gowns you are seeking to procure? Additionally, 510Ks already meet specified standards that the FDA has deemed to be safe for their intended use. Thus, if you simply designate the AAMI PB70 standard along with a requirement to properly manufacture under a 510K for FDA product code FYA then it greatly simplifies the requisite standards and specifications already determined to meet FDA requirements, including flammability. Please note, that there are a number of contract manufacturers in the U.S. manufacturing surgical gowns under 510Ks that are “licensed” from the 510K owner and then solicited to the government. It is improper to for a contract manufacturer to solicit the gowns it manufactures—FDA law expressly prohibits a contract manufacturer from distributing the gowns it contract manufactures. Thus, explicitly prohibiting the practice of allowing contract manufacturers to act as offerors OR only inviting 510K owners (manufacturers) to act as offerors will greatly reduce the risk of protest on your procurement.

As per the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH), “Many companies do not physically make their own devices but are the legal manufacturers of the device and are called specification developers. In such cases, they would "contract" the manufacturing to a contract manufacturer and provide them all the information needed to make sure the device meets the specifications cleared by the FDA under the 510(k). The law requires both manufacturers, specification developer and contract manufacturer, to register and list the device with the FDA. There are times when there may be an agreement between the two companies and it would allow the contract manufacturer to also distribute the same product under their name. This is a business discussion that the FDA is not involved with as long as the device meets regulatory requirements. If the contract manufacturer is not given permission by the specification developer to also distribute the device and they still wish to, then they must submit their own 510(k) application to the FDA for clearance prior to marketing. [As such]…” The stakeholder should make sure the device is legally marketed in the U.S. and meet all applicable regulatory requirements and also "Made in America", as part of the compliance with the Infrastructure Investment and Jobs Act.”

For additional information on how to get a device onto the market, please review the How to Study and Market Your Device website.

2. With reference to the above subject solicitation, it is identified as Made in America PPE. I want to confirm that ONLY Domestically made PPE will be considered, as within the documents it does ask to identify foreign-made products.

At this time, the Government will only consider domestically made PPE.

3. Table 4 in Attachment 2 (page 6) provides requirements for PPE. The mask type for respirators is “N95 particulate respirator”. Would any N95 respirator, including elastomeric respirators, that pass the certification testing listed in the table be considered for the solicitation?

Responsive Offerors may provide any PPE that meet certification standards and IIJA requirements for consideration.

4. Section 17 of the RFP defines the evaluation factors for the solicitation. The highest weight of 50% is given to Factor A, which is defined as technical expertise. We are a new company and don’t have sales volumes identified in the proposal. We have vast technical expertise in respiratory protection design and manufacturing. Our product was specifically designed to guard against supply chain and manufacturing interruptions. It seems disadvantageous for new, innovative companies to put such a high emphasis on prior sales vs. the product and the plan the company has to achieve the sales volumes. Would you consider revising this section to be more inclusive of newer companies and innovative products? If not, would we have the opportunity not to respond to this section and be given a neutral score?

Evaluation of demonstrated experience will be based on the evaluation criteria within the solicitation.

5. You show an image of a basic DuPont Tyvek coverall. Yet you specify multiple ASTM standards. This would require different suits/materials to meet those requirements, i.e flame retardant, chemical resistance etc. It will require different suits and materials for some of those ASTM requirements. I want to clarify we would need to respond with different items per ASTM requirements.

The picture provided was for illustrative purposes only and not intended to represent every PPE coverall in industry. Responsive Offerors must meet the ASTM standards, certifications, and other required specifications for the PPE that they are proposing to the Government.

6. Do you have a breakdown of pair/and/or each usage of gloves by each type including the specs for the type of glove? Also, do you have the dollar value for each?

Proposed Utilization Estimates are listed on Attachment 2, Page 4, Table 1.

7. Should freight/shipping cost be included in the pricing quoted?

Pricing of items offered shall be all inclusive.

8. Is a new Excel needed for each product submitted within a CLIN or should Tabs be added to the bottom of the Excel spreadsheet?

Offerors should add a new tab, as necessary for each product they intend to submit. Please add a new Tab and label it with the appropriate CLIN. For example, if you are submitting pricing for CLIN 9, CLIN 9a would then be the next tab after CLIN 9. Please make sure to label within the table what 9a or the like signifies (what PPE is being offered to the Government). Please also ensure you appropriately attribute the related volume discounts for each PPE product being offered in the excel tab (i.e. 9a-01, 9a-02, and so on) .

9. For the samples to be sent is a box of the product or a single item required?

Samples provided should follow the instructions within the RFP/solicitation. For each PPE offered, a sample needs to be provided (including 1/size offered). All samples must be provided in the by sales unit and within original packaging with manufacturer and product details. No more than one sample per contract line item proposed shall be submitted to the Government to determine whether items meet specifications for anticipated use. Samples must be sent in the packaging that will be sold to and by the NIHSC. This is critical to the packing validation that characteristics are MADE IN USA markings are on every material. Information concerning submitting samples are detailed further in Page 18 of the solicitation.

10. To comply with IIJA compliance, is the product required to be 55% or 100% sourced from and made in the USA?

100%. Compliance with Subtitle C of title IX of Division G, “ Make PPE in America” (the “Act”) of the Infrastructure Investment and Jobs Act (Pub. L. 117-58) (“IIJA”) requires 100% American manufactured, 100% American sourced components for Personal Protective Equipment being offered to the Government. (See also Section 16.1 of the RFP/Solicitation).

11. Will there be a set aside portion for Certified MBE or other socio-economic classes?

Per the solicitation, 40% of the multiple awards are reserved for small businesses.

12. Will there be special consideration if we partnered with a non-minority offeror as a minority sub-contractor?

No special consideration will be given.

13. The document file/name - “RFP 75N98023R0014 Final 63023.docx” lists the Solicitation Number on the document as: RFP 75N98023R000014, yet the other files named have either two or three “0s”. Please reference the png file attached. Can you please confirm that all files regardless of their file names are all associated with the main notice id?

The RFP Number is 75N98023R00014 (three zeros) and all files name are associated with RFP 75N98023R00014.

14. Of the $99,000,000.00 expected maximum value, do you have any estimated spend amount for respirator masks, (Surgical/N95 Respirators) as listed in “Background” section of PPE?

Proposed Utilization Estimates are listed on Attachment 2 of the RFP/Solicitation.

15. It appears this solicitation is specific to NIH procurement. Is there participation by other federal government agencies that plan to purchase products resulting from awards? If yes, what agencies?

This RFP/solicitation is for the potential use of all HHS and its subagencies (staff divisions and operations divisions), inclusive of NIH.

16. Can you provide total historical and/or estimated usage for each PPE category/CLIN?

Proposed Utilization Estimates are listed on Attachment 2 of the RFP/Solicitation.

17. What is the estimated award date and date of initial delivery orders?

The Award date of any RFP/solicitation is entirely dependent on the number of responsive offers received by the Government for the PPE requirements. The Government will begin to evaluate responsive offers after the due date identified in the RFP/solicitation in this Q4 of FY23.

18. Under which CLIN should isolation gowns be offered?

CLIN VII.

19. The solicitation states “Offerors are required to provide proof of IIJA compliance”. What specific certifications or documented proof of IIJA compliance are required? (i.e. How does an offeror PROVE that each product component is 100% American sourced other than with offeror affirmation on Form 4?)

Self-Certification of complying with IIJA is through the offeror accurately completing and submitting affirmation on Form 4 of the RFP/solicitation. Please note, a manufacturer must have a competent and reliable evidence to support the claim that all of the product is made in the USA, identifying the component sourcing with specificity. Under its general authority to act against deceptive acts and practices, the Federal Trade Commission (FTC) controls ‘Made in America’, ‘Made in the USA’, or any claims of U.S. origin for all products sold or advertised in the United States. If it later determined that a certification made by an offeror is untrue, that offeror shall be deemed ineligible.

20. Given HHSAR Clause 352.225-70, would any raw materials originating from outside of the United States, but reprocessed or reused in the United States be considered 100% domestic components?

Please see answer to question 2, above.

21. Attachment 3 states that all shipments must be bar coded, with scanned bar codes only reading the National Stock Number (NSN). Will only products that have NSN’s be accepted for this Contract?

No. However, bar coding for scan capability is a requirement. Related stock numbers will be provided, as necessary, to the contract awardee for appropriate labeling/barcoding.

22. Attachment 3 states that all products must be loaded on 42” x 40” pallets. Standard pallets are 48” x 40”, will those be accepted instead?

Standard pallet dimensions (48” x 40”) will be accepted, as will 42” x 40” pallets be accepted.

23. The Delivery Requirements state that expedited delivery options may be required. Are the shipping costs of such expedited shipments to be the responsibility of the government?

Expedited delivery will be negotiated at the delivery order level.

24. How to define Made in America? By labor, by materials or both?

Please see HHSAR Clause 352.225-70 Made in America – Personal Protective Equipment for more information concerning Made in America, inclusive of definitions.

25. If a vendor claims to have 100% American-made PPE with 100% domestic components, who will verify and approve that?

Please see answer to question 19, above.

26. We would like to submit a variety of models for each CLIN, and would like clarification on how to prepare the excel file. For example, CLIN #1, Surgical Mask. We have adult and child size, how would we prepare the excel file? Our suggestion, please advise if acceptable: We will add X number of tabs to the excel file in this format CLIN 1-1, CLIN 1-2, CLIN 1-3 Please see answer to question 8 above.

27. When does NIH anticipate first contract awards to take place?

The Award date of any RFP/solicitation is entirely dependent on the number of responsive offers received by the Government for the PPE requirements. The Government will begin to evaluate responsive offers after the due date identified in the RFP/solicitation in this Q4 of FY23.

28. How long does NIH anticipate it will take to review all submissions?

The length of time it takes the Government to review all submission entirely dependent on the number of responsive offers received by the Government for the PPE requirements. Understanding that part of the submission includes samples for evaluation, the Government will undertake to evaluate all submissions with due diligence, conscientious of both time and integrity to meet mission critical requirements.

29. In the description section of the “Combined Synopsis/Solicitation”, a requirement is cited that states “…all PPE must meet the IIJA Act in its entirety, including 100% American Made, with 100% domestic components…”. However, the additional IIJA attachment only references product and performance standards and not raw material requirements. The specific product we will be responding for is Nitrile Gloves and at this stage, several of the key raw materials are not manufactured in the US in significant quantities or quality levels to support the manufacturing process. Should this simply be addressed within the technical proposal using Table B from page 10?

Compliance with Subtitle C of title IX of Division G, “ Make PPE in America” (the “Act”) of the Infrastructure Investment and Jobs Act (Pub. L. 117-58) (“IIJA”) requires 100% American manufactured, 100% American sourced components for Personal Protective Equipment being offered to the Government. (See also Section 16.1 of the RFP/Solicitation). If there are caveats, or quantity level impact due to lack of source components, this must be addressed in the Technical Proposal.

30. If the submitting party is a direct manufacturer, does the “Subcontracting Plan” still need to be submitted or addressed as part of a complete proposal?

Yes, a subcontracting plan is required if an offeror is not considered a small business under the solicitation’s NAICS code.

31. Are there a specific number/quantity of samples that should be submitted for each product?

Please see answer to question #9, above.

32. One of our partners manufactures Nitrile gloves here in Louisiana. However, they get all their Nitrile Butadiene Rubber from Nitriflex in Brazil. Is this something we can get a wavier for on this bid? Or does this automatically disqualify us from submitting?

Responsive determinations will be made upon receipt of offers. Waivers for components of PPE not being domestically sources are determined through the Made in America Office and are not being contemplated under this solicitation/RFP at this time. Per the solicitation an offeror must propose IIJA compliant products or be considered ineligible for award.

33. I noticed on the RFP it says you are looking for Small and Large N95’s. Our partner only offers Large N95’s. Can we still submit an offer for only Large N95’s?

Offerors may provide a responsive offer for any or all of the PPE requirements being sought by the Government.

34. When it comes to quotes for each CLIN. How do we quote if we have multiple items (levels) for each CLIN? I only see spaces to offer one part number per CLIN.

Offerors may propose on any item that meets the requirement for that CLIN. Please see answer to question #8, above.

35. For CLIN 1 does this cover procedure masks, surgical masks, non-medical barrier face covering, and clear masks? I do not see a sperate CLIN for each one of these masks.

Yes, it does include these. Please see answer to question #8.

36. Technical Specs: In Attachment 2, Table 4, for N95 Particulate Respirators, the proposal included a reference to 29 CFR 1910.124. Was this a typing error and should the reference be to be 29 CFR 1910.134 instead?

Thank you for catching the typing error. Correct, it should be 29 CFR 1910.134.

37. In which month and year does NIH anticipate awarding contract(s)?

Please see answer to question #17.

38. In which month and year does NIH anticipate delivery of the first task/delivery order?

Please see answer to question #17.

39. Can NIH provide a CLIN level ceiling by year and over the entire period of performance?

There is no CLIN ceiling level; just a ceiling for the base period and option periods for a grand ceiling of $99M.

40. Is there a specific surge capacity that NIH is seeking? This is important to understand in order to allocate sufficient production surge capacity.

Awardee/offerors shall demonstrate the ability “meet and sustain” product shipments on a recurring monthly basis, and up to twice weekly as required for inventory replenishment.

Please see Attachment 7, Form 4 of the solicitation.

41. How many total awards (large and small business) are expected? This is important for demand planning.

The Government anticipates multiple awards, but the specific number is unknown at this time.

42. Is the minimum order value $10,000 or $5,000? (Refer to RFP Page 2, 2. Minimum and Maximum Contract Amounts and RFP Page 7, FAR Clause 52.216-19 Order Limitations, a) Minimum Order) .

$10,000 is the minimum guarantee for the IDIQ contract; whereas $5,000 is minimum order limitation.

43. Can multiple lot numbers of a product be mixed or co-mingled within a case?

Multiple lot numbers should not be co-mingled and/or mixed within a case. Each case should contain one lot number, but multiple lot numbers (by case) will be accepted on a pallet.

44. If a pallet contains cases of a single product, are all cases required to have the same lot Pallets received with multiple lot numbers (by case) will be accepted, and a single lot number by pallet is not required.

45. Are both of the following packaging options for a product acceptable: 100 eaches loosely packaged within a case and 100 eaches packaged as 10 each/inner box and 10 inner boxes within a case?

The referenced packaging options are acceptable for every PPE commodity except gloves. Standard packaging for nitrile/latex gloves is 100 each per box and 10 boxes per case.

46. If special delivery options, such as overnight/expedited delivery, are requested by the NIH, will the contractor or NIH be responsible for any additional delivery costs? (Refer to Attachment 3, Delivery Requirements, paragraph J and Attachment 3, Shipping Requirements, paragraph H).

Please see answer to question 23.

47. In Attachment 7, Form 4, Column O “Current Capability (Qty & UoM)”, request that NIH further define the term (e.g. sustainment capacity/month, surge capacity/month, etc.).

Awardee/offerors shall demonstrate the ability “meet and sustain” product shipments up to twice weekly as required for inventory replenishment.

48. In Attachment 7, Form 4, Column P “Can Meet and Sustain Shipment Frequency up to 2x/week (Y/N)”, request that NIH further define the term “Sustainment Shipment” in terms of quantity of 2x/week recurring shipments expected.

Awardee/offerors shall demonstrate the ability “meet and sustain” product shipments on a recurring monthly basis, and up to twice weekly as required for inventory replenishment.

49. For Factor A “Technical Expertise” it appears there are three (3) subfactors – “Demonstrated Experience”, “Sample of IIJA Compliant PPE offered for Government Evaluation”, and “Project Plan”. How will these subfactors be weighted and/or contribute towards the Factor A’s “50%” Weight?

i – IIJA compliant 50% (out of the 50% weight) ii – Experience 25% (out of the 50% weight) iii – Project Plan 25% (out of the 50% weight)

50. Can NIH further define the term “Proposed Utilization (Estimates)” in Attachment 2, Table 4 “Expected utilization of masks and associated certifications” since it appears ambiguous within the RFP?

Proposed Utilization Estimates are listed on Attachment 2, Page 4, Table 1. The Government has projected utilization rates based on enterprise purchasing normalized over the past 5 years. The Government intends to handle delivery orders on a monthly basis.

51. In 16. “STATEMENT OF THE EVALUATION FACTORS AND THEIR RELATIVE ORDER OF IMPORTANCE” it states, “For this solicitation, all technical evaluation factors are significantly more important than cost or price.” Please clarify – is it all technical factors individually or all technical factors combined are significantly more important than cost or price?

The language has been amended to read: “For this solicitation, all technical evaluation factors and past performance, when combined, are significantly more important than cost or price.”

52. Since “IIJA Compliance” is a GO/NO-GO threshold requirement, how does compliance with 52.225-3 “Buy American-Free Trade Agreements-Israeli Trade Act” and 52.225-5 “Trade Agreements” considered since they are marked as required?

Both 52.225-3 “Buy American-Free Trade Agreements-Israeli Trade Act” and 52.225-5 “Trade Agreements” are removed from this requirement via Amendment #5.

53. For period of performance, please clarify whether there are 2 or 3 one-year option periods? In the RFP, page 3, paragraph 3. Period of Performance it states, “...a base period of two years from date of award, two one-year option periods (a possible 4-year timeframe in total).” whereas the Attachment 1 Pricelist Final 063023 includes an Option Year 3 for each CLIN.

This has been amended to delete the third option year within the Excel spreadsheet, via Amendment #5.

54. Will price increases/decreases be allowed during option periods?

The awardee(s) can always discount prices during base or option periods; however, pricing may not be increased unless approved by both the NIH and the contractor.

55. Please confirm the correct RFP number to include on proposals is 75N98023R00014. (Refer to RFP 75N98023R0014 appearing in the RFP file title and 75N98023R000014 appearing within the RFP document.)

Please see answer to question #13.

56. Does the requestor have an estimated quantity of each item?

Proposed Utilization Estimates are listed on Attachment 2, Page 4, Table 1.

57. What would be the frequency of delivery per clin.

The Government will look to consolidate delivery orders on a monthly basis for efficiencies. However, it may be necessary during surge requirements, up to twice weekly as required for inventory replenishment.

58. Anticipated Award date after receipt of proposals?

Please see answer to question #17, above.

59. We are planning on being responsive to the RFP 75N98023R00014. We manufacture nitrile exam gloves in the USA; however, our NBR raw material is made in a TAA-compliant country (not in USA) because there is ZERO domestic raw material available. If we are responsive to this RFP, will we be automatically disqualified from consideration due to our products not meeting the 100% domestic content requirement in the Make PPE in America/IIJA acts?

Responsive determinations will be made upon receipt of offers. Waivers for components of PPE not being domestically sources are determined through the Made in America Office and are not being contemplated under this solicitation/RFP at this time. Per the solicitation an offeror must propose IIJA compliant products or be considered ineligible for award.

60. Are all technical specifications for the requested PPE included in Attachment 2, IIJA Compliant PPE Specifications, Certification Levels, and Attributes?

Contractors may propose any IIJA compliant PPE under this solicitation/RFP. While these are the known PPE requirements anticipated at the time of posting, there may be additional PPE that would be of benefit to the Government. To that end, the proposed PPE must be IIJA compliant and meet the prevailing government standards and certifications that exist for the PPE being proposed.

61. Will the government accept multiple proposed products for each CLIN if there are multiple options that meet the specifications? For example, CLIN 1, surgical masks- there are several options available that would match the RFQ technical specifications and meet IIJA compliance requirements.

Please see answer to question 34.

62. What documentation is required to meet the standards of “Made in America Certification documentation”?

Please see answer to question 19.

63. Re: Attachment 3- Shipping, Packaging, Marking etc Requirements- for bulk packaging, is it acceptable to affix a barcode to the outside of the pallet?

Barcodes must be affixed to each respective case (at a minimum) for shipments arriving on a pallet. Every individual package shipped to/received by the Government warehouse must have a barcode on its packaging. Barcoding cannot be done by pallet.

64. We will be applying to the solicitation ourselves as a small business manufacturer, however, we have been reached out to by several SDVOSB businesses that are telling us they want to respond themselves and use us as the manufacturer behind them.

a. Is that ok for them to do?

This is your company’s decision.

b. Is there a set aside for them?

There is a 40% small business reserve on this requirement.

c. Will it affect OUR response if you see someone else applying and using us as their manufacturer?

It does not affect your response. Proposals will be evaluated against the evaluation criteria.

65. Our standard pallet size is 40” x 48”. The pallet size in the solicitation states 42” x 40”. Please clarify that is the correct pallet size as it does not seem to be the standard size.

Standard pallet dimensions (48” x 40”) will be accepted, as will 42” x 40” pallets be accepted.

66. Regarding the NSN required on the labeling – will this NSN be provided to the contract awardee so that this labeling can be created?

Related stock numbers will be provided to the contract awardee for appropriate labeling/barcoding. Assigned stock numbers will primarily include local (to NIH) stock numbers.

67. Under Attachment #4 – We have updated our SAM registration. We must still complete all sections under paragraphs (c) through (v), to my understanding. Is that correct?

Please follow the provision which states: “The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

68. If we are submitting for only one item, masks, but offer several different options (i.e. ASTM F2100 Level 1, 2, 3 facemasks), we need to complete a sheet on the pricelist for each individual mask part number, correct?

Yes, that is correct.

69. It indicates only one sample per CLIN. This is not possible. Based on some of your ASTM requirements more than one item is needed to provide coverage of those ASTM requirements. We need to provide options for each ASTM. Based on the number of questions that need clarification, will you be willing to extend the due date?

Please see amendment #4 for extension.

70. Will the government please clarify that 40% of the funding for this requirement is going to small business?

40% of the IDIQ awards are reserved for small business; not funding as that is determined on the delivery order level.

71. Is this requirement fully funded and the funds are obligated for two years with $99 million in funding?

Funding is put on the contracts via delivery order; not on the base contract itself.

72. Will the government give higher "technical expertise" evaluation ratings to small business concerns that specifically supported the federal government during COVID?

Contractors (small and large) will be evaluated according to the evaluation factors located within the solicitation.

73. Will the government please give priority evaluation and higher evaluation ratings to those small business entities which maintained their $5,600 FDA registration in the interest of supporting the federal government?

Please see answer to question 72.

74. Will the government please give priority evaluation and higher evaluation ratings to those small business entities which have gone through the process of getting their own 510(k) for various products?

Please see answer to question 72.

75. Will the government please give priority to small businesses that have a 510(k) versus large businesses with a 510(k)?

Please see answer to question 72 above.

76. If large businesses are awarded on this contract, how does the government intend to hold large businesses accountable for utilizing small business concerns in accordance with small business utilization plans?

The NIH will follow the Federal Acquisition Regulation when it comes to the subcontracting plan.

77. How does the government plan to evaluate price reasonableness from large businesses?

The NIH will use various techniques to determine price reasonableness.

78. Will the government give higher evaluation priority and higher evaluation ratings to those small businesses that are already listing their Made in America PPE on a Federal Supply Schedule?

No.

79. Does the government plan to compete this requirement as LPTA or Best Value? If LPTA, then large businesses will have a significant and unfair advantage in competing based on price.

Best Value, per the solicitation: “all technical evaluation factors and past performance, when combined, are significantly more important than cost or price.”

80. May we propose other CLINs of PPE items that are commonly used by NIH?

Yes. Please see answer to questions 34 and 8.

81. What is the shipping address for these products?

Shipping addresses will vary by delivery order. Most products will be shipped to NIH offices within Bethesda, Gaithersburg, Rockville, Frederick, and Baltimore, Maryland while others will go to other facilities within the continental US.

82. With regards to physical samples, does the government want an entire box of the sample (i.e. a box of coveralls, a box of gloves, etc) or just one physical example of the product (i.e. one coverall, one gown, one glove)?

Please see answer to question 9.

83. Attachment 2 references "proposed utilization." Is this in reference to the percentage of funding that is expected to be used for that item? For example, on page 8 it shows Lab Coats and says "proposed utilization 50%." Does that mean 50% of the $99 million in funding will go to lab coats?

Proposed utilization is based on historic demand and these are provided as estimates only. Please See also answers to questions 50 and 14 above.

84. Will the government please confirm that higher preference and higher evaluation ratings will be given to offerors that show lab testing from American labs?

Please see answer to question 72.

85. In determining the successfulness of an offeror to determine if they will be awarded an IDIQ, is the evaluation performed by Best Value or LPTA?

Please see answer to question 79.

86. If a product is submitted by both a large business and a small business, and all evaluation factors are roughly equal (excluding price), will the government please give preferential evaluation to the small business concern?

Please see answer to questions 11 and 72.

87. There are several different variations of the solicitation # throughout the documentation, including 75N98023R0014, 75N98023R00014, and 75N98023R000014. Please confirm which is correct.

Please see answer to question 13.

88. The duration of the contract is identified as a potential (4) years throughout the RFP inclusive of a 2-yr base period and (2) potential 1-yr option periods; however, the PriceList spreadsheet provided for offeror completion requests pricing for (2) base years, listed separately + (3) option years, for a total of (5) years. Please confirm whether you wish offerors to complete Option Yr 3 pricing for each of the (10) CLINs.

Please see answer to question 53.

89. As you may know, nitrile butadiene rubber (NBR), the raw material used to produce nitrile gloves, is not currently available as a U.S.-manufactured component. Will there be a waiver granted for the U.S. manufacture of nitrile gloves using foreign-sourced NBR?

Please see answer to question 59.

90. If a waiver is issued, would preference be given for manufacturers that procure the NBR from TAA-compliant countries vs NBR from a non-TAA source?

Please see answer to question 59.

91. If I understand the solicitation correctly, by listing it as IIJA compliant implies that companies that received gov’t funding under the Infrastructure & Grant Act will be given preference. If correct, why would U.S. manufacturers that did not take Government funding but yet have PPE available be relegated to a lesser position in line to receive an award?

The NIH is requesting offerors submit IIJA compliant products regardless of its funding it received under other grants.

92. We notice there are no quantities or even anticipated requirements per line item. Can you please provide the anticipated quantities required?

Proposed Utilization Estimates are listed on Attachment 2, Page 4, Table 1.

93. The pricing sheet mentions CLINs, however, there is no table identifying the CLIN to Items. Do you expect us to assign our own CLINS to products offered?

Please see Answer 8 above.

94. Will quantities be required on a recurring basis, to enable stable/consistent production and workforce (steady state production)?

The Government intends to handle delivery orders on a monthly basis for consistency.

95. How does the government intend to handle delivery orders? Once per quarter? Once per week? Will the government keep these orders consistent?

The Government intends to handle delivery orders on a monthly basis.

96. Samples, what is the submission qty, you state one each. Does that mean one item or one shipping unit of measure (ie: one box or one pair of gloves (removed from box and separately packaged with information)? Please clarify these requirements.

Please see answer to question 9.

97. Will this contract require any storage/warehousing and or inventory management?

Offeror should demonstrate the benefit to the government their proposed method of meeting and sustaining product shipments as outlined in the RFP/solicitation on a recurring monthly basis, and up to twice weekly as required for inventory replenishment. If this includes options or assumptions of vendor managed inventory, that should be explained and may be considered.

98. Will vendors be required to keep a specified amount of supplies on hand along with a replenishment schedule?

This is a contractor decision. Offerors must be able to demonstrate the ability “meet and sustain” product shipments on a recurring monthly basis, and up to twice weekly as required for inventory replenishment.

99. Must all of the lab reports show the same exact model number of the isolation gown?

The last testing report results should correlate to the specific PPE model that is being offered.

100. Should the receiving warehouses be unable to accommodate delivery, will the manufacturer be held liable for delivered goods not meeting the stated shelf-life requirement?

Delivery schedules will be closely monitored between the government and suppliers. The receiving warehouse is an essential government function and will be able to accommodate deliveries.

101. Will responses provided by large businesses with existing contracts for receiving and storing HHS/SNS medical products be allowed to compete in this RFP given their unique advantage and associated conflicts of interest?

Any contractor that can supply the required products may submit a proposal for this solicitation.

102. Will contractors supplying product be allowed to inspect the delivery location to ensure property custody and care of the product prior to HHS’s acceptance inspection?

Facility inspections will not be granted. To ensure “custody and care of the product”, offerors shall package and ship samples accordingly.

103. Will the government prioritize US-based small companies over large companies?

Please see answer to question 11.

104. There is a contradiction regarding the Page Limit for Surge Capacity Statement. On Pg 14 of the RFP, the Pg limit is mentioned as "up to three pages", whereas on Pg 21 of the RFP, the Pg limit mentioned for Surge Capacity Statement is 2 Pages.

The solicitation has been amended to state on page 21 that the Surge Capacity Statement is limited to up to 3 pages.

105.On Pg 21 of the RFP, under Page limitations, one of the bulleted points listed is Delivery Volume and Schedule Written Plan. This requirement was however not described under FACTOR B: Delivery Volume and Schedule (Pg 14). Therefore, if you could provide some guidance on what points the offerors should address for Delivery Volume and Schedule Written Plan, that would be very helpful.

Awardee/offerors shall demonstrate the ability “meet and sustain” product requirements with shipments on a monthly basis and up to twice weekly as required for inventory replenishment. Proposed Utilization Estimates are listed on Attachment 2, Page 4, Table 1. Offerors should address their volume and schedule capability for the PPE they are offering to the Government.

106.On Pg 14 and 17 of the RFP, it is mentioned that Completed Form 4 should be included under Factor B: Delivery Volume and Schedule in the Technical Proposal. However, since Form 4 is an Excel attachment, and in Proposal Submission, it is advised to submit the Technical Proposal as a single pdf file, how do you suggest that we include Form 4 in the Technical Proposal pdf? Would including a snapshot of the Completed Form 4 Excel sheet in the Technical proposal suffice?

Yes.

107.The offeror is a reseller, in the case of Surge Capability under a Force Majeure event, will the government issue Rated Orders to assure priority fulfillment?

While it is impossible to determine at this time, the Government does reserve the right, through the delegated powers of the Secretary of the U.S. Department of Health and Human Services, with respect to health resources (of which PPE is a part), under the Defense Production Act ("DPA"), 50 U.S.C. § 4511 and the related Executive Order 12919 to place priority-rated orders with industry. Under the Federal Priorities and Allocation System ("FPAS"), fulfillment of a rated order must take precedence over all unrated government or commercial orders when necessary for the contractor to meet the order's delivery requirements.

108.In the case of a Force Majeure or customer needs, will the government allow substitution of a different manufacturer?

The Government reserves the right to determine this at the time of delivery order level.

109.Will non-domestic sources be allowed under an exceptional Surge situation or declared emergency?

This is not being considered at this time.

110. Is contractor expected to supply overnight/expedited delivery at no additional charge?

Please see answer to question 23.

111. Form 4 Question- Offeror is a reseller, are you requesting a point of contact for the manufacturers whose products we will be offering?

Offeror should provide all relevant points of contact for offered PPE up to and including source/manufacturer for substantiation/validation.

112.If 100% of the product components are not sources within the United States will that product be ineligible?

The contractor will not be considered for award and therefore ineligible.

113.Form 4 Question-Column O “Current Capability (Qty & UoM)”, Please clarify the meaning. Are you asking what quantity can immediately ship within one week?

Please see answer to question 14.

114.Form Question-Please clarify level of detail for UoM. For example “1 case of 10 boxes” or “1 case of 10 boxes, 100 each per box” or “1 case of 1000 ea”. Please include examples of how to represent UoM.

The level of detail should be sufficient to provide industry standards for the product being offered in the volume and packaging to meet the needs of the Government. To the extent it’s relevant to the PPE being offered, the level of detail should be, for example “1 case of 10 boxes, 100 each per box” 115.Where on the proposal will the cases per pallet information be reported?

Offerors must address cases per pallet on all documentation (proposal, invoice, and delivery documentation). It is up to you (offeror) on where you address it when responding to shipment and delivery frequency.

116.Attachment 3 shipping packaging says: “The Contractor shall clearly identify the quantity of units per case, and the quantity of cases per pallet on the proposal, invoice, and delivery documentation.” Where on the proposal will the cases per pallet information be reported?

See answer to question 6.

117. Can the NIH please help clarify how the Levels of protection stated in Table 6 of Attachment #2 translate to that of the standards stated in PB70 for Medical Isolation gowns (Level 1,2,3 &4 protection).

It is the offeror’s responsibility to demonstrate how the product offered meets the standards and classifications listed. For more information on the standards listed in Table 6 of Attachment 2, please reference OSHA PPE information and EPA PPE information.

118. Are we required to list the GSM of the material on all of the lab testing reports?

Yes.

119. Will the government confirm that lab testing from within the United States going back to March of 2020 is acceptable? For example, a lab test will not be disqualified if it is from 2+ years ago?

The vendor must demonstrate that the product offered has met the requirements stated in the referenced standards. If referenced standards have been updated since the last lab testing date, the vendor must demonstrate that the products meet the current standards.

120. Concerning Attachment 7 Form 4 Excel Sheet. Can you please provide a Sample entry as an example?

The information being requested is offeror specific. Therefore, it is up to the offeror to fill out and the Government will not be providing an example. To the extent there are assumptions, caveats or additional information that you find necessary to add context in addition to responding to the requested fields, please add a field for notes and/or supportive information.